Roslin Cells and Sistemic are to partner on the development of new technologies for standardizing the manufacture of stem cells for applications in cell therapy and drug development screening. The collaboration will exploit Roslin Cells’ expertise in GMP stem cell production and Sistemic’s SistemQC™ microRNA platform for cell characterization and monitoring of production quality control.

Sistemic maintains the stem cell community is in general agreement that there are currently no tools available that can adequately be used to monitor the quality and standardization of stem cells used in clinical applications. “We have been using our SistemQC microRNA-based service with clients working in these fields to help them gain a greater molecular understanding of their stem cell systems and have built a comprehensive understanding of the issues this sector currently faces,” claims Jim Reid, CEO. “We have been looking both at early characterization during the R&D phase, right through to generating microRNA fingerprints which can be used in the release of products from manufacture.”

Roslin Cells is focused on generating stem cells to GMP standard for therapeutic applications as well as research and drug development. The firm maintains that the collaboration with Sistemic will further allow it to ensure the optimum standards for stem cell production, from development through to scale-up and commercial manufacture. “Data from cell characterization tests are an essential element of what we provide to our customers and collaborators,” comments Aidan Courtney, CEO. “This collaboration with Sistemic will enable us to improve our production processes and deliver more extensive and valuable data to those using our cells.”

Launched in September 2010, the SistemQC platform essentially monitors stem cells to ensure the maintenance of identity, pluripotency, and differentiation status. The firm claims the platform essentially assesses the functional competence of cells using microRNA profiling to generate a read-out of the physiological status of cells and simultaneously provide potential insights into the underlying biological effect associated with any changes observed. Sistemic claims SistemQC represents a simplified platform for monitoring the maintenance of pluripotency across passages, the staging of directed differentiation, and the competence and stability of cells generated for clinical use.

SistemQC is founded on the firm’s enabling platform, SistemRNA, which profiles microRNA expression to provide a fingerprint of the cell system and identify changes in response to stimuli. The platform forms the basis of a range of tools and services offered by Sistemic for drug development. SistemKB™ is a reference database of microRNA profiles of gold standard compounds, based on selected key microRNAs (kmiRs). The firm claims identification of this small subset of kmiRs allows the effects of drug candidates or other stimuli on cellular response to be compared against the gold standards, establish biological relevance, and provide insights into cellular pathways and networks involved in drug activity and cellular responses, including the identification of on/off targets.